Iclusig FDA Investigation
The United States FDA is currently investigating an increasing number of reports regarding serious, adverse health events suffered by patients taking Iclusig, a drug approved less than a year ago for the treatment of chronic myeloid leukemia. The drug is primarily used among patients who were either unable to tolerate other treatments for the disease or who were not responding to those other treatments. At the time of Iclusig’s approval and release, the FDA stated the drug was being approved more than three months ahead of the goal date of March, 2013.
The FDA reviewed Iclusig under an expedited six-month review for new drugs which could potentially provide effective therapy when no alternative therapies exist. This program provides earlier access of promising new drugs to patients who may not have time to wait, however the manufacturer—Ariad Pharmaceutical, in this case—must continue to conduct additional therapies to confirm the clinical benefits and safety of the drug. Iclusig is one of five drugs currently on the market which blocks specific proteins which promote the development of cancerous cells. Iclusig is primarily used in those with resistant leukemia, or those which accelerated chronic myeloid leukemia. Iclusig was the third drug approved in 2012 to treat CML.
Iclusig FDA Adverse Reports
The safety and efficacy of Iclusig were evaluated in a single clinical trial which contained only 449 patients; there was no control group, all patients were treated with Iclusig. Fifty-four percent of all patients with CML achieved MCyR (major cytogenetic response), after taking Iclusig for a median duration of 9.5 months and 31 patients achieved MCyR after taking the drug for a median duration of 4.7 months. On October 11, 2013, the FDA announced it was investigating an increased frequency of adverse reports of serious, life-threatening blood clots and narrowing of arteries and veins among those taking Iclusig. The FDA noted that physicians should determine on a case-by-case basis whether the benefits of Iclusig are likely to exceed the known risks.
Iclusig FDA Warnings
Data from the clinical trial and postmarket adverse reports indicate that patients taking Iclusig may suffer such serious symptoms as chest pain, chest pressure, pain in the arms, back, neck or jaw, shortness of breath, symptoms of stroke such as numbness or weakness on one side of the body, difficulty speaking, severe headache and dizziness. An increased frequency of serious, life-threatening blood clots has been seen in those taking Iclusig as well as:
- Worsening coronary artery disease
- Narrowing of large arteries to the brain
- Severe narrowing of blood vessels in the extremities
- The need for urgent surgical procedures to restore blood flow
- Congestive heart failure
- Decreased vision
- Clots in the blood vessels of the eye
- Liver failure
- Hypertensive crisis
- Fluid retention
- Compromised wound healing
- Gastrointestinal perforation
- Abdominal pain
- Chronic headache, constipation, dry skin, anemia and fatigue
The FDA noted that in some cases serious problems or even death occurred as soon as two weeks after patients began taking Iclusig, and in some cases those problems or deaths occurred in young patients with no risk factors for heart disease.
Iclusig FDA Warnings
As many as 5,000 new cases of chronic myeloid leukemia are diagnosed each year in the United States, while over 600 patients will die from the disease each year. The cost of Iclusig can be prohibitive for many, costing approximately $115,000 per year, with an expectation that the patient could remain on the drug for life. Ariad Pharmaceuticals marketed Iclusig as being a part of a revolution which could transform the disease of CML from a death sentence to a chronic disease. Patients with a mutation which render their cancer resistant to the drug Gleevec or related drugs are primary candidates for Iclusig therapy.
Gleevec, a small-molecule drug available since 2001, is often known as the “poster child of personalized medicine.” Unfortunately, many patients who initially respond well to Gleevec, will experience a return of the cancer which then becomes resistant to Gleevec. Ariad executives publicly took issue with the FDA’s approach; while acknowledging that Iclusig may need to be restricted to a smaller set of patients, the company maintained suspended sales were only to allow them to design a revised drug label. FDA officials noted they would continue to work with Ariad in order to further understand the risks of Iclusig as well as identifying the specific patient population whose benefits from Iclusig could outweigh the risks.
The attorneys of Sullo & Sullo have experience helping those who have been harmed by a drug they were told was safe. Sullo & Sullo attorneys will conduct a thorough evaluation of your individual case then clearly lay out all options.